drugset / Trial / NCT01400412
Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen
Phase 2
Completed
262 enrolled
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The main purpose of this study was to compare the effects on bones of the following two drug combinations: * maraviroc (MVC), emtricitabine (FTC), plus darunavir/ritonavir (DRV/r) * tenofovir (TDF) plus emtricitabine (FTC) plus darunavir/ritonavir (DRV/r) Additional study objectives were the following: * To see how the drug combinations affect the brain and kidneys. * To see how well the drug combinations lower the HIV viral load. * To see how safe the drug combinations are, how well people are able to take the study drug combinations, and how well their immune systems respond to the study drugs.
Timeline
- Start
- 2012-01-17
- Primary completion
- 2014-06-30
- Completion
- 2014-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Maraviroc | Other / unclassified | 150 mg | Oral |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Background | Darunavir | Small molecule | 800 mg | Oral |
| Background | Ritonavir | Other / unclassified | 100 mg | Oral |
| Background | emtricitabine | Other / unclassified | 200 mg | Oral |